Effectiveness of the Ivivi Torino II, Pulsed Radio Frequency Device, on Narcotic Use, Pain and Quality of Life Following Shoulder Arthroscopic Rotator Cuff Repair.

Impact of Non-thermal Pulsed Radio Frequency (PRF)on Narcotic Use, Pain, and Health-related Quality of Life Following Shoulder Arthroscopic Rotator Cuff Repair: A Double-Blind, Randomized Sham-Controlled Trial

To determine the effectiveness of non-thermal PRF delivered with the Ivivi Torino II on narcotic use, pain, and health-related quality of life following shoulder arthroscopic rotator cuff surgery comparing: Active treatment versus placebo (Sham).

Study Overview

• Status: Terminated
• Conditions: Rotator Cuff Tear
• Intervention / Treatment: Device: Ivivi Torino II; Device: Inactive Sham device

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University School of Medicine
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Mississippi Sports Medicine and Orthopaedic Center
  • New Mexico
    • Taos, New Mexico, United States, 87571
      • Taos Orthopaedic Institue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• MRI diagnosis of rotator cuff tear
• Persistent symptoms despite a minimum of 6 months of failed non-operative management
• Scheduled for primary or revision arthroscopic rotator cuff repair (with or without any of the following: debridement, subacromial decompression, distal clavicle resection, treatment of biceps tendon and /or glenoid labrum pathology, release of capsule).
• Age 40 to 80 years
• Able to read and complete English-language surveys
• Ability of the participant to comprehend the full nature and purpose of the study including possible risks and side effects
• Willingness and ability to comply with study product and methods

Exclusion Criteria:

• Diagnosis of adhesive capsulitis requiring global capsular release, instability, fracture, or arthritis
• Any implanted metallic leads, wires, or systems (e.g. pacemaker, implantable cardioverter-defibrillator)
• Known narcotic allergy, hepatitis, nephritis, or gastrointestinal ulcer
• Chronic narcotic pain medication dependency
• Vulnerable populations including prisoners, pregnant women, nursing home residents, the Investigator's students and employees, employees of sponsor, those unable to consent for themselves, uninsured subjects or others who could be subject coercion
• Worker's compensation claimant
• Medical condition, in the judgement of the patient's physician, which may interfere with the shoulder surgery or the effectiveness or safety of the study treatment
• Use of oral prednisone in the past 30 days
• Use of any investigational drug or participation in another research study within the past 30 days
• Self-reported diagnosis of autoimmune or inflammatory arthritis (e.g. Rheumatoid Arthritis, Lupus, ets.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Ivivi Torino II; Active treatment with Non-thermal Pulsed Radio Frequency device	Device: Ivivi Torino II; Emits a PRF generated specific electromagnetic signal consisting of a 27.12 MHz radio frequency carrier pulse-modulated with a burst duration of 3 milliseconds repeating at 2 times per second (2Hza0>
SHAM_COMPARATOR: Inactive Sham; Sham treatment	Device: Inactive Sham device; The inactive control device (Sham) identical to the Active device with the exception that a PRF signal is not delivered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average daily narcotic consumption (oxycodone mg)	Average, daily, patient-reported narcotic consumption (converted to oxycodone equivalents in mg) during Week 1.	week-1 post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average daily narcotic consumption (oxycodone mg)	Average, daily, patient-reported narcotic consumption during Weeks 2-6	Weeks 2-6 post surgery
Visual Analogue Scale (VAS) pain	Daily VAS pain (daily "current" and "maximum") during Week 1, VAS pain (daily "current" and "maximum") during Weeks 2-6	Weeks 2-6 post surgery
Patient-reported general health-related quality of life score (EQ-5D)	The EQ-5D will be completed by the subject on the last day of each week (Weeks 1-6)	On the last day of Weeks 1-6
Adverse Events	Adverse events will be recorded daily following randomization and analyzed for confirmation of device safety	Weeks 1-6 post surgery

Collaborators and Investigators

• Sponsor: Amp Orthopedics, Inc.
• Investigators: Principal Investigator: Felix Savoie, M.D., Tulane University Schol of Medicine

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (ANTICIPATED): September 1, 2012
• Study Completion (ANTICIPATED): October 1, 2012

Study Registration Dates

• First Submitted: January 9, 2012
• First Submitted That Met QC Criteria: January 10, 2012
• First Posted (ESTIMATE): January 11, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 9, 2012
• Last Update Submitted That Met QC Criteria: July 6, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Non-invasive; Arthroscopic Rotator Cuff Repair; Electromagnetic field treatment; Pulsed Radio Frequency treatment; Non-thermal
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: Amp-PostOpShoulder-Pain-001